510(k) Report

Devices descending from K974789

653 later devices reach Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+7K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+7K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+7K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+7K241656Eneka SelectifTermosalud20241—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K241406LavieenWontech Co., Ltd.20242—
+7K233123SilkroHironic Co., Ltd.20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K234057NirvanaEl.En S.P.A.20240—
+7K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K232236EchoQuanta System Spa20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+7K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K202172StarWalkerFotona D.O.O.20203—
+7K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesLumenis, Ltd.20201—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+7K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193426Elite iQCynosure, LLC20201—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K172413MT ONEM&T S.R.L.20175—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170908PK AIMGyrus Acmi, Inc.20170—
+7K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K161038PK MorcellatorGyrus Acmi, Inc.20160—
+7K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+7K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+7K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+7K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K142350PK J-HookGyrus Acmi, Inc.201511
+7K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+7K142093V20 SystemViora, Ltd.201432—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K131839DC 7Dc International, LLC20130—
+7K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+7K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K122605PKS BillGyrus Acmi, Inc.20121—
+7K102366Finess EndoscopeEntellus Medical, Inc.20110—
+7K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+7K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+7K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+7K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+7K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+7K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+7K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+8K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+8K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+8K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—